Precision medicine studies have been boosted by 21st Century Cures funding. | Courtesy of Shutterstock
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John Breslin | Dec 12, 2016

Precision medicine studies boosted by 21st Century Cures funding

Major funding has been awarded to companies charged with building the foundation for the future of precision, or individualized, medicine.

Five companies have begun to enroll 1 million or more people in one of the most ambitious health studies ever carried out in the United States.

Funding is provided following the passage of the 21st Century Cures Act, which delegates more than $6 billion for research, $500 million to the FDA and grants for the prevention and treatment of opioid abuse, passed overwhelmingly by both the House and Senate.

Additionally, some $4.8 billion will be available via the National Institutes of Health for the Precision Medicine Initiative, as well as brain and cancer research.

NIH has awarded a grant totaling $207 million over five years to five companies to build the foundation for the Precision Medicine Initiative (PMI), which was announced by President Barack Obama in his 2015 State of the Union address.

“We are leading efforts in the new Precision Medicine Initiative, and got additional funding via the 21st Century Cures Act, to advance the field,” Dr. Eric Topol, of the San Diego-based Scripps Transitional Science Institute, told Patient Daily. “(It’s) not just genomics, but also sensors and many other facets of medicine. Add physical therapy to the list.”

The PMI Cohort Program seeks to enroll 1 million or more U.S. volunteers by 2020 in the long-term research effort.

Participants will provide a variety of data including information from their electronic health records, health questionnaires and mobile health data on lifestyle factors and environmental exposures. Furthermore, they will undergo a baseline physical evaluation and provide blood and urine samples, according to Scripps.

“By doing so, participants will enable researchers to translate the information collected from the cohort into new medical knowledge and treatments,” according to a company statement. “Importantly, the participants themselves will have access to their study results as well as summarized data from across the cohort.”

Precision medicine is often thought of as matching up one’s genetics with the right medication, Topol stated.

“But is far broader than that, extending to who should get screened for what condition and determining which labs, scans and devices are best suited for any given patient,” he said. “As my experience demonstrates, it even encompasses how physical therapy should be tailored.”

It is unclear at this stage how precision medicine will affect insurance.

“It’s going to be tough: different medical providers, insurers, Medicare and Medicaid will be figuring out how to fit it all together and give patients the best quality care at the lowest price,” Dr. Laurence Altshuler, of the Cancer Treatment Centers of America, told HealthPayerIntelligence.  

For an op-ed piece in the Washington Post, Topol described how, following knee surgery, he was helped by an individualized physical therapy plan.

“The individualized nature of this new plan, which she would have initiated immediately after the surgery for me, was epitomized by her handwritten page of instructions, not the typical preprinted handout for one treatment fits all,” he said. “Most people do well with intensive physical therapy, but for me it backfired and set up a vicious cycle of inflammation. I needed a different protocol than the standard one that works for the majority. I needed a protocol for patients with histories and conditions like mine.”

The five companies involved in the cohort program will be responsible for creating mobile apps to enroll, gain consent, collect data from and communicate with those participating.

“This range of information at the scale of 1 million people from all walks of life will be an unprecedented resource for researchers working to understand all of the factors that influence health and disease,” National Institutes of Health Director Dr. Francis Collins said in a statement.

This initiative aims to tackle a range of complications, including several cancers and multiple chronic diseases like diabetes, heart disease and Alzheimer’s -- as well as mental illnesses like depression, bipolar disorder and schizophrenia.

Scripps was founded in 2006 with one aim: to individualize health care by leveraging the remarkable progress being made in human genomics and combining it with the power of wireless digital technologies.

By recognizing that every patient is unique, individualized health care tailors medical care to the individual patient, taking into account not only a person’s genes but also their environment, behavior and lifestyle, according to the company mission statement.

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